País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
BICALUTAMIDE
LTT Pharma Limited
BICALUTAMIDE
50 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Withdrawn
2013-03-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Casodex 50 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 50mg bicalutamide Excipient: contains lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Italy_ Round, white, biconvex tablet intagliated with "Cdx50" on one face and a logo on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adult males including the elderly: One tablet (50mg) once a day. Treatment with Casodex should be started at the same time as treatment with an LHRH analogue or surgical castration. Children: Casodex is contraindicated in children. Renal Impairment: No dosage adjustment is necessary for patients with renal impairment. Hepatic Impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (_see section 4.4, Special warnings and_ _precautions for use_). 4.3 CONTRAINDICATIONS Casodex is contra-indicated in females and children (see section 4.6). Casodex must not be given to any patient who has shown a hypersensitivity reaction to the active substance or to any of the excipients of this product. Co-administration of terfenadine, astemizole or cisapride with Casodex is contraindicated (see section 4.5) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 14/02/2012_ _CRN 2103544_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Initiation of treatment shou Leia o documento completo